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510(k) K153417

Device
ST AIA-PACK PROG III Calibrator Set
Applicant
TOSOH BIOSCIENCE, INC.
510(k) number
K153417
Product code
JIT  
Decision
Substantially Equivalent (SESE)
Decision date
2015-12-18
Date received
2015-11-25
Regulation
862.1150
Classification name
Calibrator, Secondary
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ROBERT L. WICK
Address
6000 Shoreline Ct., Suite 101 South San Franciso CA US 94080 94080

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JIT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics2017-05-16
K170938CalSet IGF-1Roche Diagnostics2017-04-26
K170160Abbott ARCHITECT Free T3Abbott Laboratories2017-02-15
K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.2017-01-13
K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.2017-01-13
K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc.2017-01-12
K163544Lumipulse G ProlactinFujirebio Diagnostics,Inc.2017-01-12
K163078DC-UIBC-CALSekisui Diagnostics P.E.I., Inc.2016-12-08
K163053Lumipulse G E2-III CalibratorsFujirebio Diagnostics,Inc.2016-12-01
K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSiemens Healthcare Diagnostics2016-11-17
K160113ST AIA-PACK hsE2 Calibrator SetTosoh Bioscience, Inc.2016-02-17
K152526Elecsys Progesterone III CalSetRoche Diagnostics2015-10-02
K151566Abbott ARCHITECT Total T4 CalibratorsAbbott Laboratories2015-07-10
K142985UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL CalibratorBeckman Coulter, Inc.2015-02-26
K143342Elecsys T-Uptake CalsetRoche Diagnostics2014-12-19

Legacy Summary#

summary

FDA Review#

Decision Summary